JDE For Life Sciences

Madhav Garikapati

Agenda
1 2 Life Sciences Overview Wipro JDE Pharma Solution Proposition

2009 Wipro Ltd - Confidential

Life Sciences

Life Sciences consists of Pharmaceutical Medical Equipment manufacturers

2009 Wipro Ltd - Confidential

Pharmaceutical Overview
Characteristics of Pharmaceutical Company

API Active potent Ingredients Expiration dating heavily regulated Lengthy quality test duration Long product development cycles (+7 years) FDA approval mandates production process Out of spec results require written deviations EBR, Electronic batch Records Cont .. Typically discrete manufacturing End to end Factory Audits are mandatory

Characteristics of a Medical Devices Company

Characteristics of a Medical Devices Company

Complex manufacturing process High growth industry but many small players Contract manufacturing is typical Outside sterilization tracking can be complex Kitting & Return to refurbish is typical CAPA, Corrective & preventative action DHR, Device History Records Typically Lean manufacturing focused Contract management highly regulated
5

Wipro JDE PHARMA Solution Proposition

2010 Wipro Ltd - Confidential

Typical Pharma Requirements

Advanced Lot Control consisting of new lot dates, lot effective dates, percentage of remaining life, manufactured item expired date calculation & mass lot expiration update Conditional Lot Processing meaning the lot is not available for selling to outside customers but available for transactions like sales transfers. Lot trace & track For medicines return it can be effectively managed through return material authorization Batch wise costing & price management Ability to store & retrieve multiple prices like customer price, MRP, Wholesale price etc

Ability to calculate different taxes on different type of medicines. Some medicines have VAT, some have no tax etc.
As the supply chain process is all dependent on credit cycles, it is important to track & control business transactions on credit limit & credit aging Quality being a mandatory requirement, drugs having batch short expiry dates have to be prevented from transactions

Cont ..
7

Typical Pharma Requirements (Cont..)

Another Pharma requirement is expired batches need to be taken back from customers. Different Scenarios here can be Products taken back here & customers given credit Note Good Products taken back which can be sold to other customers (Sales Return) Products taken back & replacement products given etc.

Some other Pharma requirements can be It is important in to track the product packaging details like number of boxes, cases etc & print it on the invoice. To mention the drug manufacturer details of the batch on the invoice

Client Specific Process Improvements 1.JDE E1 compliance today happens through a batch job after entry. Because of this some orders can be struck which is a good thing. As a process improvement the compliance can be taken forward to happen at order entry stage itself by building a matrix for item vs. customer(Product Vs Hospital or Pharmacy) 11.Pricing which happens through BAM can be totally configured to be done in E1. Third one is 21CFR11 21CFR11 validation This is a very important requirement with Pharma. This consists of Audit Table Trigger

Cont ..

Typical Pharma Requirements (Cont..)

Audit Table triggers: As per FDA regulations any columns in any tables can be set up for table audit triggers. Once activated, if any value is changed then the old value as well as the new value is stored in the shadow table along with the user name and machine IP. JD Edwards Enterprise One provides the capability to select specific columns in a table for auditing. You can configure JD Edwards Enterprise One to generate an audit table when table records are inserted, updated, or deleted. The audit records contain data such as: Before and after values Time and date of the transaction The user who made the modification Electronic Signature: In addition, we can configure JD Edwards Enterprise One interactive and batch applications to require an electronic signature approval when a user tries to change the data on an application or submit a report. A record of the approval is recorded in the Signature table (F9500005). The table records this information: Approver of the change Reason for the approval Approver's user ID Users role Date and time of the approval

Cont ..
9

Typical Pharma Requirements (Cont..)

We can view the information in the audit and electronic signature tables using the View Audit/Signature Information application (P9500005) or by generating reports (R9500004, R9500005, R9600006). The reports display all the audit and signature information in an easy-to-read Adobe Acrobat PDF file that can be printed to hard copy or saved in digital format.

Cont ..
10

Example for Electronic Signature

11

Electronic Sign (Cont..)

You have two choices to initiate electronic signature. Either update lot status code or update lot expiration from Lot dates

12

Electronic Sign (Cont..)

By making changes to Lot expiration dates electronic signature is initiated

13

Electronic Sign (Cont..)

This is the electronic signature that requests user id (JDE), reason code(3) and password (JDE) to accept the Update. Comment field is for additional information

14

View Audit & Signature Information in JDE

In work with audit & signature information select signature & audit

15

View Audit & Signature Information in JDE

This is the electronic registration of changes that affected the table that you have enabled auditing. You can also display the columns that were changed by showing before & after images. Select the row to view the before & after image
16

View Audit & Signature Information in JDE

17

Thank You

2010 Wipro Ltd - Confidential